Omicron boosters from Pfizer, Moderna cleared by FDA for younger children
Children as young as 5 years old can now receive an updated COVID-19 booster following a decision by the Food and Drug Administration to expand its authorization of reformulated shots from Moderna and partners Pfizer and BioNTech.
Moderna’s vaccine, which was previously cleared in adults 18 years and older, is authorized for use in children at least 6 years of age. Pfizer and BioNTech’s vaccine can now be used in children 5 years old and up, after previously being available for those 12 years or older.
The FDA’s authorizations come a little less than three weeks after the companies submitted applications to expand use of their updated shots, which are adapted to better protect against the omicron variants that are currently most prevalent in the U.S.
“Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19,” Peter Marks, the head of the FDA’s Center for Biologics Evaluation and Research, said in a statement on the authorizations.
“While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized,” he added.
The FDA based its decision on immune response and safety results from clinical trials that tested other versions of the companies’ updated boosters, which the regulator viewed as “relevant and supportive” to its decision. The agency also reviewed data on the companies’ original booster doses, which have been widely used.
The new boosters contain genetic sequences encoding for the spike proteins found on both the original coronavirus strain and the BA.4/BA.5 omicron strains.
The agency first authorized omicron boosters for adults and, in the case of Pfizer and BioNTech’s, older children at the end of August. They are meant to be given at least two months after the primary two-dose series or initial booster vaccination of either shot.
So far, however, uptake has been comparatively slower, with only 11.5 million people receiving an updated vaccine dose, according to data from the Centers for Disease Control and Prevention. Overall, about half of Americans who completed their initial vaccination series, or about 110 million people, have gotten a booster.
Cases of COVID-19 have fallen to an average of about 40,000 a day in the U.S., according to tracking by The New York Times. Around 400 people die from the disease each day.
Health officials have been concerned those numbers could creep back up with children starting school and people spending more time inside as the weather gets colder. Immunity in people vaccinated many months previously has likely waned as well, leaving them more vulnerable to infectious variants like omicron and its related substrains.
“We have seen an increase in COVID infections, hospitalizations, and deaths each of the last two winters,” said Ashish Jha, the White House’s COVID-19 response coordinator, in a press briefing Tuesday. “We are carefully monitoring the rise of several subvariants that are evolving rapidly and emerging around the world, including ones that evade some of our treatments.”
But the White House has also faced challenges in communicating caution, particularly after President Joe Biden declared in an interview last month that “the pandemic is over.”
“We’re out there doing everything we can to make sure that that message is getting out there and helping people understand that if you want to stay safe and healthy this fall and winter, the best thing you can do is get vaccinated,” said Jha.
As a result of the FDA’s decision, Pfizer’s prior booster shot, which only contained the original coronavirus strain, is no longer authorized for children ages 5 to 11 years old.
Both Pfizer’s and Moderna’s original vaccines remain available for a primary two-dose series in young infants and children older than 6 months.